An approvable letter is sent by the FDA when a drugmaker's New Drug Application is not sufficient for approval, but has the potential to be approved at a later date. The letter spells out what problems the FDA had with the marketing application. Often times further meetings with the FDA are required to determine what needs to be done to get the drug approved.
Recent Mentions on Fool.com
- Congress and Hospitals Team Up For Veterans' Medical Care
- Biotechnology: Investing Essentials
- Tesla Motors, Inc. Announces Deal With Panasonic on the Gigafactory
- Are You Really Approved for That Home Loan?
- Monday?s Top Health Care Stories: AcelRx, Horizon Pharma, Hospira, GSK
- 3 Future Biotechnology Blockbusters?